Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

FDA Not A Good FRAME for CDMO Inspections?

Is the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) a good idea? It dates to 2019, but as of this July, the FDA has proposed a regulatory pathway allowing a distributed manufacturing establishment (DME) to operate as a single registrant covering multiple locations. Let's look at a real-life example to weigh the merits.

GUEST COLUMNISTS

AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

PHARMA OUTSOURCING WHITE PAPERS

From Process Monitoring To Manufacturing Intelligence: Real-Time Analytics And Predictive Control In Biomanufacturing
Advanced analytics, predictive modeling, explainable AI, and digital twins are helping biomanufacturers improve process visibility, anticipate outcomes, and support smarter operational decisions.

Performance Characteristics Of The Mobius® ADC Reactor For Conjugation
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
Insights And Effective Strategies For A Successful Technology Transfer
Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.
Why Get Cleaning Validation Support From The Cleaner Supplier?
Standardize compliant cleaning by integrating risk-based validation, effective residue detection, and science-based limits to reduce cross-contamination and protect product quality.
Speeding Up Safety: An Evaluation Of Mycoplasma Technology
Rapid mycoplasma testing enhances cell and gene therapy safety by reducing turnaround time, minimizing sample needs, and delivering sensitive, reliable contamination detection across diverse matrices.
Applications Of Liquid-Filled Capsules For Challenging APIs In Pharmaceutical Manufacturing
Discover the benefits of liquid-filled capsules for efficient, scalable, and patient-friendly drug manufacturing, and how they can enhance bioavailability and simplify complex formulations.